News & Research

A-HYDROCORT SUMMARY

A-Hydrocort sterile powder contains hydrocortisone sodium succinate as the active ingredient. Hydrocortisone sodium succinate, is a white, or nearly white, odorless, hygroscopic, amorphous solid. It is very soluble in water and in alcohol, very slightly soluble in acetone and insoluble in chloroform.

When oral therapy is not feasible, and the strength,
dosage form and route of administration of the drug reasonably lend
the preparation to the treatment of the condition, A-Hydrocort sterile
powder is indicated for intravenous or intramuscular use in the following
conditions:

1. Endocrine
Disorders

Primary or secondary adrenocortical insufficiency
(hydrocortisone or cortisone is the drug of choice; synthetic analogs
may be used in conjunction with mineralocorticoids where applicable;
in infancy, mineralocorticoid supplementation is of particular importance)

Acute adrenocortical insufficiency (hydrocortisone
or cortisone is the drug of choice; mineralocorticoid supplementation
may be necessary, particularly when synthetic analogs are used)

Preoperatively and in the event of serious trauma
or illness, in patients with known adrenal insufficiency or when adrenocortical
reserve is doubtful

Shock unresponsive to conventional therapy if adrenocortical
insufficiency exists or is suspected

Congenital adrenal hyperplasia

Hypercalcemia associated with cancer

Nonsuppurative thyroiditis

2. Rheumatic Disorders

As adjunctive therapy for short-term
administration (to tide the patient over an acute episode or exacerbation)
in:

Comparison of Two Forms of Hydrocortisone in Patients With Congenital Adrenal Hyperplasia [Completed]
This study will test a new, extended release form of hydrocortisone called Chronocort in
patients with congenital adrenal hyperplasia (CAH). People with CAH do not make enough of
the adrenal hormones cortisol and aldosterone, and their adrenal glands make too much of the
sex hormone androgen. Medicines called glucocorticoids (hydrocortisone, dexamethasone and
prednisone) are currently used to treat CAH, but finding the best dose of these drugs that
effectively lowers androgens without causing undesirable side effects, such as weight gain
and slow growth rate in children, is often difficult to achieve.
Adolescents and adults with CAH due to 21-hydroxylase deficiency may be eligible for this
study. Children 16 years of age and older are eligible with confirmation by bone age that
they are no longer growing.
Participants undergo the following tests and procedures during two inpatient visits one
month apart at the NIH Clinical Center:

- Medical history and physical examination.

- Medications: Following 7 days of Cortef (standard drug treatment for CAH), patients

begin taking Chronocort on day 3 of hospitalization and continue the tablets once a day
for 1 month.

- Blood tests: A catheter (plastic tube) is inserted in a vein and left in place for

frequent blood draws in order to avoid repeated needlesticks. Blood is drawn for
chemistries, blood count, pregnancy test in women, and for serial tests (up to 26
samples in a 24-hour period) to measure hormone levels.

- 24-hour urine test.

- Height and weight measurements.

Between the two hospitalizations, patients are contacted by NIH weekly to check for possible
side effects from Chronocort. Two weeks after the first visit, patients also will have blood
drawn by their regular doctor or a local clinic. A few days before the second
hospitalization, patients undergo a 20-minute telephone questionnaire about energy level and
well being.
About 30 days after discharge from the second hospitalization, patients are followed up with
a telephone call to see how they are doing.

Sensitivity of Short and Long Allele Carriers of the 5-HTTLPR to Environmental Threat Post Hydrocortisone Administration [Completed]
The current study will test the causal relationship between elevated levels of cortisol and
the serotonin transporter gene (5-HTTLPR) as these factors influence sensitivity to
environmental threat. The investigators predict that carriers of the short allele of the
serotonin transporter gene who have elevated cortisol levels will be most sensitive to
threatening environments, whereas carriers of the long allele who do not have elevated
cortisol (placebo subjects) will be least sensitive.